Gliederung

Dihydroartemisinin/Piperaquine is a fixed-dose Artemisinin-based Combination Therapy (ACT) which contains dihydroartemisinin (DHA), a derivative of artemisinin, and piperaquine (PQP).

It has been developed for the treatment of uncomplicated Plasmodium falciparum malaria. The registration Dossier has been filed to EMA in July 2009 and after the EU registration it will be submitted to the countries where malaria is endemic.

Artemisinin is extracted from the Artemisia annua plant, which was used for many centuries in China as traditional medicine for the “treatment of fever”. It was extracted and purified during the 70's and three derivatives have been produced (artesunate, artemether and dihydroartemisinin). The ACTs' strategy is based on the concept that the combination reduces the chances of resistance developing and improves its efficacy.

The treatment schedule is one daily administration for a total of 3 days.

The clinical development included two large phase III comparative clinical trials, carried out in Africa and Asia, with a total of about 2,700 patients treated, all of them with uncomplicated P. falciparum malaria. The trial in Africa included about 1,600 children from 6 months to 5 years and the comparator was artemether-lumefantrine. The second phase III trial was carried out in Asia in about 1,200 patients (from 6 months to 63 years) and the comparator was artesunate-mefloquine. The results of the two phase III trials confirmed the efficacy and safety of Dihydroartemisinin/Piperaquine as well as the prophylactic effect in lowering the incidence of new infections during the follow up periods which were of 42 days in Africa and 63 days in Asia, in comparison with the other ACTs utilized.